Safety and efficacy of the traditional Chinese medicine chaihu guizhi ganjiang decoction combined with wendan decoction in the treatment of premature ejaculation: an open-label retrospective cohort study on Chinese men

Background: Chaihu Guizhi Ganjiang Decoction combined with Wendan Decoction (CGGWD) is used clinically to treat liver depression and spleen deficiency-related premature ejaculation (PE), while clinical evidence and safety are still limited. Aim: To assess the safety and efficacy of the Traditional Chinese Medicine (TCM) formula, CGGWD, in comparison with dapoxetine for PE. Methods: This retrospective study included male PE patients with liver depression and spleen deficiency treated at a prominent academic medical center (November 2021-March 2025). Patients completed a 4-week regimen, with sexual function and systemic symptoms evaluated before and after treatment. Outcomes: Outcomes were determined based on assessment of intravaginal ejaculatory latency time (IELT), Premature Ejaculation Diagnostic Tool (PEDT), Traditional Chinese Medicine Quality of Life Evaluation Scale (CQ-11D), Global Rating of Sexual Satisfaction (GRISS), and Clinical General Impression of Change (CGIC). Results: < .05). Clinical Implications: The TCM formulation, CGGWD, demonstrates both safety and efficacy in the management of PE. Strengths and Limitations: This study offers the initial clinical validation of CGGWD for PE but is limited by population selection constraints, potential information bias, and unobserved confounding factors. Conclusion: For Chinese men with liver depression and spleen deficiency PE, CGGWD matches dapoxetine in efficacy but offers superior safety and systemic symptom relief, serving as a safe, effective alternative.